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San Francisco, CA

Adam Dudik, M.S.

Senior Specialist

Adam has over a decade of experience in the biotechnology industry providing regulatory advice, leadership, and strategy for various clients. His expertise is in multiple therapeutic areas, such as immunology, oncology, pulmonology, and neurology. He has vast experience in various stages of drug development, from pre-IND/IND to late-stage development and supplemental BLA. He is proficient in all stages of biologics development with broad knowledge of the product lifecycle from research and discovery through commercialization. At Halloran, Adam provides regulatory support for product development programs ranging from early stage to late-stage development.

Prior to joining Halloran, Adam held roles of increasing responsibility at various biotechnology companies. He was a regulatory consultant for multiple startups providing early regulatory strategy, development plans, and submission support. Prior to that he worked in the oncology space developing a late-stage product for synovial sarcoma and an early-stage IND for hepatocellular carcinoma. Before that he managed a lean regulatory team that was responsible for the successful approval of their BLA. Over the years, Adam has developed strong relationships with regulatory authorities, facilitating effective communication and negotiation during the product approval process. His expertise extends to both domestic and international regulations, having successfully led product approval campaigns in multiple countries.

Education:
Cal State Channel Islands, MS, Biotechnology and Bioinformatics
Sonoma State University, BS, Biology